All files submitted should not be file protected or locked. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. New european regulation for medical devices to replace 93. Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. Medical devices directive 9342ec evaluation and testing. Directive 9342eec concer ning medical devices oj l 28, 4. Medical devices internal market, industry, entrepreneurship.
Directive 9879ec of the european parliament and of the council of 27 october 1998. These are, for example, additional equipment or singleuse devices. Medical device manufacturers were able to apply the medical device directive on january 1, 1995. Directive 200070ec of the european parliament and of the council of 16 november 2000 amending council directive 93 42 eec as regards medical devices incorporating stable derivates of human blood or human plasma.
Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. May 27, 2011 when medical device companies do business in europe, they are required to conform to the eus medical device directive, 93 42 eec. F2 labs can perform the emc and safety testing that is required by the medical device directive for. European union 2 the eu is a unique economic and political partnership between 28 european countries that together cover much of the continent. F2 labs can perform the emc and safety testing that is required by the medical device directive for medical electrical products. Medical device directive mdd9342eec the medical device directive was published in 1993 by the european commission. Directive 9342eec covering medical devices modified by the directive 200747ce ivdd. Conformity assessment is the method by which a manufacturer demonstrates that their devices comply with the requirements of directive 9342 eec. The requirements for the technical documentation are laid down in the various annexes of the medical devices directives, as appropriate for the conformity assessment procedure and the products concerned. One important way to comply is to use the applicable standards from the harmonised list for medical devices.
Three different directives are applicable to different types of medical devices in europe. Personnel responsible for quality systems for medical device manufacturers will benefit from this. Directive 9342 means council directive 9342eec of 14 june 1993 concerning medical devices. Eu medical devices directive mdd 9342eec and the coming eu medical devices regulation similarities and ex pected differences dr. If the documentation is submitted in more than one files, each file should be titled and numbered. Directive 90385eec covering active implantable medical devices modified by the directive 200747ce mdd. Medical device directive mdd93 42 eec the medical device directive was published in 1993 by the european commission. A proposal for a medical devices regulation combining and superseding the existing directives 90385eec and 9342eec.
These accessories are such objects which are themsleves no device, but according to the manufacturer, have a fixed purpose in connection with the device. Mdr designated notified body mdr guidance documents meddev. Medical device directive mdd 9342eec as amended by 200742ec pavan kumar malwade 01 april 2016 1 2. The revision of the european medical device directive 93 42 eec and the work of study group.
Directive 9342ec on medical devices mdd and directive 9879ec on in vitro diagnostic medical devices ivdd will be repealed once the mdr and ivdr are fully applicable. Both the medical device directive 93 42 eec and the active implantable medical devices directive 90385 eec have been modified by a new directive 200747ce. Contents of technical documentation for mdd 9342eec and. Both the medical devices directive 9342eec and in vitro diagnostic medical device directive 9879ec require manufacturers or, their authorised representatives or others placing medical devices on the eea market, to provide certain information to the competent authorities in the eea member state where they have a registered place of. This section shows you chapterspecific coding guidelines to increase your understanding and correct usage of. Understanding the medical devices directive 9342 eec directive 9342eec of the european union eu also known as the medical devices directive mdd details the essential requirements manufacturers and importers must meet to apply the ce mark and legally market or sell their devices in the eu. The medical device directive council directive 93 42 eec of 14 june 1993 concerning medical devices, oj no l 1691 of 19930712 is intended to harmonise the laws relating to medical devices within the european union. On the one hand, however, the scope is extended to some products currently not covered by the aimddmdd. Council directive 9342eec of 14 june 1993 concerning medical devices. If the device is intended for use in combination with other devices or equipment, the whole. It is based on a variety of guidance documents produced by various organisations as well as specific material produced by.
European medical device directive essential requirements checklist. Nbog documents for medical device directives 90385eec, 9342eec and 9879ec. Product placement on the market cannot be prevented by any eu country if a device caries a ce mark which is a confirmation that this device meets the basic requirements according to annex 3. Medical device regulation published in the official.
New european regulation for medical devices to replace 9342. B council directive 93 42 eec of 14 june 1993 concerning medical devices the council of the european communities, having regard to the treaty establishing the european economic community, and in particular article 100a thereof, having regard to the proposal from the commission 1, in cooperation with the european parliament 2. Freezer certified as a medical device according to directive 9342eec. Council directive 9342eec of 14 june 1993 concerning medical devices the council of the european communities, having regard to the treaty establishing the european economic community, and in particular article 100a thereof, having regard to the proposal from the commission 1, in cooperation with the european parliament 2. Directive 9879ec covering in vitro diagnostic medical devices some amending medical directives human tissue, breast implants. This applies for medical devices requiring the ce mark in europe. The medical practitioner or other authorized person must have access to the technical and clinical data regarding the device. Equipped with a microprocessor and large 7 digital display, ideal for longterm storage at ver. Harmonized european standards, available for a fee. Council directive 9342eec of 14 june 1993 concerning medical devices this document comes with our free notification service, good for the life of the document. The essential requirements of the medical device directive 9342 eec referred to as the mdd set out the detailed requirements for labelling of medical devices in annex 1 paragraphs 8.
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents b council directive of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices 90385 eec oj l 189, 20. Medical devices guidance document classification of. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. At that time, the manufacturers had the choice to apply either national regulation or the medical device directive.
So 9342eec has been amended 5 times, by 9879ec, 200070ec, 2001104ec, 200332ec, and 200747ec. Council directive 93 42 eec of 14 june 1993 concerning medical devices. F1 substituted by directive 200747ec of the european parliament and of the council of 5 september 2007 amending council directive 90385 eec on the approximation of the laws of the member states relating to active implantable medical devices, council directive 93 42 eec concerning medical devices and directive 988ec concerning the placing. The european medical devices directive mdd, directive 9342eec requires manufacturers. European medical device directive essential requirements. The concept of compatibility between medical devices is dealt with in annex i of directive 9342eec relating to the essential requirements applicable to medical devices, under the following points. The medical devices directive aims to ensure the free movement of goods within the community, while providing patients, users and third parties with a high level of protection and attaining the levels of performance attributed to the medical devices.
The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device on the european market the requirements of the md. These sections are reproduced below for your information or. Classification, indicating the rule bullet point according to annex ix of directive 93 42 eec statement as to whether the ingredients of the product include a substance as defined in annex i section 7. Directive 9368 eec ce marking directive 9879ec of the european parliament and of the council of 27 october 1998 on. As a general rule, the documentation should cover the design, manufacture and intended operation of. This document is meant purely as a documentation tool and the. Conformity with medical device directive 9342 eec is mandatory all devices that fit the definition of a and its accessories this directive is of the regulation remains pending. The written report, signed by the medical practitioner or other authorized person responsible, must contain a critical evaluation of. The medical device directive council directive 9342eec of 14 june 1993 concerning medical devices, oj no l 1691 of 19930712 is intended to harmonise the laws relating to medical devices within the european union. This document is meant purely as a documentation tool and. If hard copies are submitted, these will be converted to. Bsis european medical devices directive requirements course is designed to provide a top level overview of the guidelines of the european medical device directives mdd 9342eec and comprehensive information on the mdd 200747 changes. In common with other new approach directives, the three medical device directives in place include provisions for mandatory ce marking of all products covered by them. Directive 2001104ec of the european parliament and of the council text with eea relevance of 7 december 2001.
B council directive 9342eec of 14 june 1993 concerning. Council directive 9342eec of 14 june 1993 concerning. Both the medical device directive 9342eec and the active implantable medical devices directive 90385eec have been modified by a new directive 200747ce. The devices must be designed and manufactured in such a way that, when used under the conditions and for. Oct 12, 2017 three different directives are applicable to different types of medical devices in europe. Iso 485 how to use it to get the medical device ce mark. Understanding the medical devices directive 9342eec directive 9342eec of the european union eu also known as the medical devices directive mdd details the essential requirements manufacturers and importers must meet to apply the ce mark and legally market or sell their devices in the eu. An official proposal is envisaged for end of september 2012. Medinfo medinfo council directive 9342eec on medical devices. The classification of the medical device will have an impact on the conformity assessment route that the manufacturer should follow in order to affix the ce marking on the medical device. Conformity with medical device directive 93 42 eec is mandatory all devices that fit the definition of a and its accessories this directive is of the regulation remains pending. Medical devices directive mdd 9342eec explained in the medical device directive m.
The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device. European medical device directive french translation linguee. There are three medical device directives in place, the directive of active implantable medical devices 90385eec, the medical devices directive 9342eec, and the directive of in vitro diagnostic medical devices 9879ec. Manufacturers must comply with the medical device directive, mdd 9342eec, in order to sell their medical products into europe. The preferred document format is pdf files with bookmarks for ease of locating specific content. Bsi training european medical devices directive requirements. Further to this, the medical device directive 9342 eec is also applicable for accessories of medical devices. Invitrodiagnostic medical devices the commission is developing two regulations.
The directive 9342eec applies for the placing on the market and launching of medical devices and their accessories. The current eu regulatory framework for medical devices, other than in vitro diagnostic medical devices, consists of council directive 90385 eec on active implantable medical devices aimdd1 and council directive 93 42 eec on medical devices mdd2 which cover a huge spectrum of products. When considering the medical device, the criteria for risk acceptability is. They areconsidered the state of the art, and are considered not mandatory but in reality you will be unable to cemark a device without the use of harmonized eu standards. Medical device directive 9342eec annex vii, risk class i compilation of the ce mark technical file systematic consulting delivery starts with an experienced regulatory affairs consultant explaining the detailed compliance project plan based on the annex vii of the medical device directive to be implemented with their guidance by phone and emails. Official journal no page date m1 council directive 9342eec of 14 june 1993 l 169 1 12. Council directive 93 42 eecof 14 june 1993 concerning medical devices oj l 169 of 12 july 1993 modification.
There are three medical device directives in place, the directive of active implantable medical devices 90385 eec, the medical devices directive 93 42 eec, and the directive of in vitro diagnostic medical devices 9879ec. Eu medical device directive 9342eec labelling requirements. Medical devices and related services organizations can be involved in one or more stages of the lifecycle including the design and development, production, storage and distribution, installation, or servicing of a medical device and the design and development or provision of associated activities e. This document is available in either paper or pdf format. The devices must be designed, manufactured and packed in such a way that their characteristics and. Freezer certified as a medical device according to directive 93 42 eec. In pla inenglish, if you place your company name on the device or label, you are the manufacturer. In the meantime, national registration requirements for devices placed on the market in accordance with the mdd and ivdd will apply until may 2020. Directive 200070ec of the european parliament and of the council of 16 november 2000. The written report, signed by the medical practitioner or other authorized person responsible, must contain a critical evaluation of all the data collected during the clinical investigation. Medical devices directive 9342eec european commission. Nist special publication 951 a guide to eu standards and. Regulation eu 2017745 on medical devices mdr has a three year transition period and is fully applicable from 26th may 2020.
As a general rule, the documentation should cover the design, manufacture and intended operation of the product. The council of the european communities, having regard to the treaty establishing the european economic community, and in particular article 100a thereof, having regard to the proposal from the commission 1, in cooperation with the european parliament 2. This section shows you chapterspecific coding guidelines to increase your understanding and correct usage of the target icd10cm volume 1 code. Luckily, there is a consolidated reprint of the medical device directive, issued in 2007, that consolidates the original text with these 5 amendments. The third directive is the in vitro diagnostics directive 9879ec. Required characteristics of guards and protective devices annex 1 of machinery directive 200642ec article 1. European commission enterprise and industry medical devices directive 93 42 eec short name. The new eu medical device regulations entered into force in may 2017. European medical device directive french translation. Because of the many types of devices covered by the mdd, the specific requirements depend on. Understanding the medical devices directive 93 42 eec directive 93 42 eec of the european union eu also known as the medical devices directive mdd details the essential requirements manufacturers and importers must meet to apply the ce mark and legally market or sell their devices in the eu. Matthias neumann german federal ministry of health, division 122 medical devices safety, friedrichstra.
Unit 4 pressure equipment, medical devices, metrology medical devices. Risks due to other hazards annex 1 of machinery directive 200642ec. The medical devices directive aims to ensure the free movement of goods within the community, while providing patients, users and third parties with a high level of protection and attaining the levels of performance attributed to the medical devices by the manufacturer. Medical device directive 9342eec cemarking qnet, llc.
555 1511 322 1187 939 346 1206 370 839 1540 608 1264 220 330 821 661 82 899 675 1589 1096 1429 250 601 1014 900 539 1020 1234 1087 1072 46 856 1036 103 69 78 1268 804 1214 12 672 640 13 346 499 276 1150 721 847